Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
NCT ID: NCT04193176
Last Updated: 2024-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
376 participants
INTERVENTIONAL
2020-05-10
2022-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Gefapixant
Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
Gefapixant
Administered twice daily as an oral tablet of 45 mg
Placebo
Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
Placebo
Administered twice daily as a placebo oral tablet matching gefapixant
Interventions
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Gefapixant
Administered twice daily as an oral tablet of 45 mg
Placebo
Administered twice daily as a placebo oral tablet matching gefapixant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has chronic cough (defined as duration of \>8 weeks after onset of cough symptoms) for ≥12 months
* Has a diagnosis of refractory chronic cough or unexplained chronic cough
* Has symptoms of SUI, defined as involuntary loss of urine on effort, physical exertion, or on sneezing or coughing, for ≥3 months
* Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
Exclusion Criteria
* Has given up smoking within 12 months of screening
* Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
* Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
* Has a history of chronic bronchitis
* Has a history of surgery to treat SUI within 1 year of screening
* Has a history of other specialized treatments for SUI, including intravesical balloon or urethral bulking agent therapy
* Has other external incontinence device currently or within 1 month of screening
* Has a history of Grade 3 or higher pelvic organ prolapse previously documented or diagnosed on screening
* Has a neurogenic bladder
* Has a history of adult nocturnal incontinence
* Has a history of continuous urine leakage within 1 month of screening
* Has a history of interstitial cystitis
* Has a history of neurological disease or injury
* Has active or recurrent urinary tract infection
* Has a history of having a permanent urinary catheter or any urinary catheterization within 3 months of screening
* Has a history of malignancy ≤5 years prior to signing informed consent
* Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
* Has a known allergy to gefapixant or its excipients
* Has donated or lost ≥1 unit (\~300 mL) of blood within 8 weeks prior to first dose of gefapixant
* Requires certain medications and/or other therapies that may impact their cough or bladder function
* Has previously received gefapixant
* Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
18 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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City Polyclinic N20 ( Site 2806)
Odesa, Odesa Oblast, Ukraine
SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817)
Kyiv, Kyivska Oblast, Ukraine
Odesa regional clinical hospital ( Site 2804)
Odesa, Odesa Oblast, Ukraine
Center for Clinical Trials, LLC ( Site 0021)
Paramount, California, United States
Health Awareness, Inc. ( Site 0038)
Jupiter, Florida, United States
Well Pharma Medical Research, Corp. ( Site 0040)
Miami, Florida, United States
Lenus Research & Medical Group Llc ( Site 0007)
Sweetwater, Florida, United States
Florida Pulmonary Research Institute, LLC ( Site 0008)
Winter Park, Florida, United States
Paul A. Shapero, MD ( Site 0037)
Bangor, Maine, United States
Chesapeake Clinical Research, Inc ( Site 0022)
White Marsh, Maryland, United States
University of Missouri ENT & Allergy Center ( Site 0010)
Columbia, Missouri, United States
Alliance for Multispecialty Research, LLC ( Site 0035)
Las Vegas, Nevada, United States
Albuquerque Clinical Trials ( Site 0019)
Albuquerque, New Mexico, United States
American Health Research ( Site 0027)
Charlotte, North Carolina, United States
Clinical Research of Gastonia ( Site 0016)
Gastonia, North Carolina, United States
PMG Research of Wilmington ( Site 0004)
Wilmington, North Carolina, United States
Temple University ( Site 0003)
Philadelphia, Pennsylvania, United States
AAPRI Clinical Research Institute ( Site 0031)
Warwick, Rhode Island, United States
Diagnostics Research Group ( Site 0013)
San Antonio, Texas, United States
TPMG Clinical Research ( Site 0025)
Newport News, Virginia, United States
Tidewater Physician Multispecialty Group, PC ( Site 0028)
Williamsburg, Virginia, United States
Bellingham Asthma & Allergy ( Site 0006)
Bellingham, Washington, United States
Centro Medico Dra De Salvo ( Site 0300)
Buenos Aires, , Argentina
Investigaciones en Patologias Respiratorias ( Site 0302)
San Miguel de Tucumán, , Argentina
Fundacion Centro de Investigacion Clinica CIC ( Site 0401)
Medellín, Antioquia, Colombia
Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408)
Medellín, Antioquia, Colombia
Medplus Medicina Prepagada ( Site 0402)
Bogotá, Bogota D.C., Colombia
Healthy Medical Center S.A.S ( Site 0404)
Zipaquirá, Cundinamarca, Colombia
Praxis Dr. Wehgartner-Winkler ( Site 0906)
Augsburg, Bavaria, Germany
Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0900)
Marburg, Hesse, Germany
Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0905)
Neu-Isenburg, Hesse, Germany
Pneumologicum im Suedstadtforum ( Site 0908)
Hanover, Lower Saxony, Germany
Praxis an der Oper ( Site 0912)
Berlin, , Germany
Bethel Soluciones Medicas S.A. ( Site 0506)
Guatemala City, , Guatemala
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0500)
Guatemala City, , Guatemala
Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504)
Guatemala City, , Guatemala
Clinica Medica Especializada en Neumologia ( Site 0502)
Guatemala City, , Guatemala
Private Clinic ( Site 0505)
Guatemala City, , Guatemala
Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503)
Guatemala City, , Guatemala
Carmel Medical Center ( Site 1104)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 1107)
Jerusalem, , Israel
Hadassah Ein Karem Jerusalem ( Site 1108)
Jerusalem, , Israel
Rabin Medical Center ( Site 1102)
Petah Tikva, , Israel
Chaim Sheba Medical Center ( Site 1101)
Ramat Gan, , Israel
Kaplan Medical Center ( Site 1103)
Rehovot, , Israel
Sourasky Medical Center ( Site 1100)
Tel Aviv, , Israel
Clinica Ricardo Palma ( Site 0601)
San Isidro, Lima region, Peru
Asociacion Civil por la Salud ( Site 0602)
Lima, , Peru
Hospital Nacional Arzobispo Loayza ( Site 0607)
Lima, , Peru
Clinica Belen ( Site 0604)
Piura, , Peru
RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1416)
Belgorod, Belgorod Oblast, Russia
GBUZ Regional Clinical Hospital 3 ( Site 1420)
Chelyabinsk, Chelyabinsk Oblast, Russia
City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1400)
Kemerovo, Kemerovo Oblast, Russia
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1466)
Moscow, Moscow, Russia
Krasnogorsk City Hospital Number 1 ( Site 1470)
Krasnogorsk, Moscow Oblast, Russia
City Clinical Hospital of Emergency Care #2 ( Site 1448)
Novosibirsk, Novosibirsk Oblast, Russia
Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1438)
Omsk, Omsk Oblast, Russia
Perm Clinical Center of the Federal Medical and Biological Agency ( Site 1450)
Perm, Permskiy Kray, Russia
Medi Kom ( Site 1456)
Saint Petersburg, Sankt-Peterburg, Russia
Limited Liability Company Kurator ( Site 1424)
Saint Petersburg, Sankt-Peterburg, Russia
SEIHPE Saint Petersburg SMU ( Site 1434)
Saint Petersburg, Sankt-Peterburg, Russia
Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1452)
Saratov, Saratov Oblast, Russia
Family Clinic ( Site 1464)
Yekaterinburg, Sverdlovsk Oblast, Russia
State health Agency Ulyanovsk regional clinical hospital ( Site 1414)
Ulyanovsk, Ulyanovsk Oblast, Russia
Voronezh Regional Clinical Hospital #1 ( Site 1440)
Voronezh, Voronezskaja Oblast, Russia
SBCIH of the Yaroslavl region Central city hospital ( Site 1428)
Yaroslavl, Yaroslavl Oblast, Russia
Jeonbuk National University Hospital ( Site 1507)
Jeonju, Jeonrabugdo, South Korea
Wonju Severance Christian Hospital ( Site 1502)
Wŏnju, Kang-won-do, South Korea
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1506)
Seoul, , South Korea
Konkuk University Medical Center ( Site 1504)
Seoul, , South Korea
Asan Medical Center ( Site 1505)
Seoul, , South Korea
Hospital Parc Tauli ( Site 1806)
Sabadell, Barcelona, Spain
Hospital Clinic i Provincial de Barcelona ( Site 1804)
Barcelona, Catalonia, Spain
Hospital Clinico Universitario de Santiago ( Site 1805)
Santiago de Compostela, La Coruna, Spain
Hospital General Universitario Gregorio Maranon ( Site 1808)
Madrid, Madrid, Comunidad de, Spain
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808)
Kyiv, Kyivska Oblast, Ukraine
F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2819)
Kyiv, Kyivska Oblast, Ukraine
SE Road Clinical Hospital 2 of Kyiv station ( Site 2812)
Kyiv, Kyivska Oblast, Ukraine
Municipal enterprise "1st City clinical hospital of Poltava -Internal medicine department ( Site 281
Poltava, Poltava Oblast, Ukraine
Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809)
Vinnytsia, Vinnytsia Oblast, Ukraine
Volyn Regional Clinical Hospital ( Site 2816)
Lutsk, Volyn Oblast, Ukraine
Medical Center of LLC Medical Clinic Blahomed ( Site 2815)
Kyiv, , Ukraine
GP Direct ( Site 2714)
Harrow, England, United Kingdom
West Walk Surgery ( Site 2700)
Yate, Gloucestershire, United Kingdom
Medinova Lakeside Dedicated Research Centre ( Site 2712)
Corby, Northamptonshire, United Kingdom
Kings College Hospital NHS Foundation Trust ( Site 2702)
London, Southwark, United Kingdom
Accellacare South London Quality Research Centre ( Site 2706)
Orpington, Surrey, United Kingdom
Wokingham Medical Centre ( Site 2708)
Wokingham, West Berkshire, United Kingdom
Medinova North London Dedicated Research Centre ( Site 2705)
Northwood, Worcestershire, United Kingdom
Medinova Warwickshire Dedicated Research Centre ( Site 2715)
Coventry, , United Kingdom
Countries
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References
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Birring SS, Cardozo L, Dmochowski R, Dicpinigaitis P, Afzal A, La Rosa C, Lu S, Nguyen AM, Yao R, Reyfman PA. Efficacy and safety of gefapixant in women with chronic cough and cough-induced stress urinary incontinence: a phase 3b, randomised, multicentre, double-blind, placebo-controlled trial. Lancet Respir Med. 2024 Nov;12(11):855-864. doi: 10.1016/S2213-2600(24)00222-4. Epub 2024 Aug 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-7264-042
Identifier Type: OTHER
Identifier Source: secondary_id
2019-002321-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7264-042
Identifier Type: -
Identifier Source: org_study_id
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